Company receives FDA IND clearance for linsitinib and prepares to initiate Phase 2b clinical trial.
| - Company receives FDA IND clearance for linsitinib and prepares to initiate Phase 2b clinical trial - ANN ARBOR, Mich., June 13, 2022 /PRNewswire/ -- Sling Therapeutics, Inc., a biopharmaceutical company focused on late-stage development of an oral small molecule for the treatment of thyroid eye disease (TED), today announced the official launch of the company with a $35M Series A financing led by TPG’s The Rise Fund. The funds will support a Phase 2b clinical trial evaluating the company’s investigational drug, linsitinib, for the treatment of TED. “We are launching Sling Therapeutics with a clinical development program that is based on an extensive amount of data with over 800 patients having received linsitinib in cancer clinical trials, which allows us to accelerate development of linsitinib in TED,” said Ryan Zeidan, Ph.D., President and Chief Executive Officer of Sling Therapeutics. “Linsitinib will be the first oral IGF-1R inhibitor to enter late-stage clinical trials for TED and we have the potential to bring a convenient orally administered drug to patients. We are pleased to have received IND clearance from the FDA and are initiating a Phase 2b study. Our goal is to significantly reduce the treatment burden for patients and the healthcare system compared to currently marketed products.” TED is a debilitating autoimmune disease that affects about 20,000 people in the U.S. per year and has a similar prevalence in Europe. The immune system mistakenly attacks the muscle and fat tissue behind the eyes, causing inflammation and scar tissue to form. The inflammation can push the eyes forward or cause the eyes and eyelids to become red and swollen. As the disease progresses it can lead to pain, eye bulging, double vision, and a profound reduction in quality of life. TED predominantly affects women, and most frequently affects people with hyperthyroidism due to Graves’ disease. Linsitinib, which was in-licensed from Astellas Pharma to Sling Therapeutics, is designed to inhibit the insulin-like growth factor I receptor (IGF-1R). Dysfunction in the IGF-1R signaling pathway leads to a prevalence of thyroid-stimulating hormone receptor autoantibodies (TSHR-Abs) that drive excess fibrous tissue growth in TED. Independent data from a model of TED in patient fibroblast cells suggest that linsitinib is at least as potent as currently available treatment.i,ii The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for linsitinib for the treatment of TED, and Sling Therapeutics is initiating a Phase 2b clinical trial. The company is also exploring additional potential indications beyond TED, including in rare and autoimmune diseases. Peter Bojo, a Principal at TPG Life Sciences Innovation, and Lucian Iancovici, M.D., Managing Director at TPG Life Sciences Innovation, will be joining the Board of Directors on behalf of The Rise Funds and are working closely with management to launch the company. Management Team Sling Therapeutics has built a management team that has extensive drug development and operations experience: Ryan Zeidan, Ph.D., President and Chief Executive Officer Dr. Zeidan was previously the chief development officer at Millendo Therapeutics and held various positions at Celgene and Novartis where he led research and development activities for late-stage assets, including rare diseases, oncology, and vaccines. He holds a B.S. in chemistry and chemical engineering from Massachusetts Institute of Technology and a Ph.D. in chemistry from The California Institute of Technology. Robin Schmidt, Chief Operating Officer Ms. Schmidt brings over 25 years of experience in clinical trial strategy and execution across large pharma, biotech and CROs. She is the former vice president of clinical operations at Millendo Therapeutics. Ms. Schmidt holds a B.S. in biology and a M.S. in nutrition from the University of Michigan. Catherine Radovich, Vice President of Clinical Operations Ms. Radovich has over 25 years’ experience in clinical trial execution and data delivery with large pharma, biotech, academic, and CROs. She previously served as the director of clinical operations at Millendo Therapeutics and is the former director of the administrative program at the Michigan Institute for Clinical and Health Research. Ms. Radovich holds a B.S. in Healthcare Management from Bellevue University. Ronald Dadino, Vice President of CMC and Manufacturing Mr. Dadino has over 35 years of experience in the development, manufacturing, and commercialization of pharmaceutical products. He holds a B.S. in Pharmacy from the University of the Sciences in Philadelphia and a M.S. in Pharmaceutical Quality Assurance and Regulatory Affairs from Temple University. About Sling Therapeutics Sling Therapeutics, Inc., is a biopharmaceutical company focused on late-stage development of an oral small molecule for the treatment of thyroid eye disease (TED). The company is advancing the evaluation of its lead product candidate, linsitinib, in a Phase 2b clinical trial based on extensive preclinical and clinical data. Linsitinib offers the potential of a convenient oral small molecule that could significantly reduce the treatment burden for people living with TED. For more information visit https://slingtx.com/. Media Contact Investor Contact
i Krieger, et al. “Inhibition of TSH/IGF-1 Receptor Crosstalk by Teprotumumab as a Treatment Modality of Thyroid Eye Disease.” The Journal of Clinical Endocrinology & Metabolism. Volume 107, Issue 4, April 2022, Pages e1653–e1660, https://doi.org/10.1210/clinem/dgab824. Published online November 12, 2021. ii Place, et al. “Inhibiting thyrotropin/insulin‐like growth factor 1 receptor crosstalk to treat Graves’ ophthalmopathy: studies in orbital fibroblasts in vitro.” Br J Pharmacol. Feb 2017; 174(4): 328–340. Published online Jan 27, 2017. doi: 10.1111/bph.13693.
SOURCE Sling Therapeutics |
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